Category: Fellows Posters
Purpose: Given the difficulty of measuring clinical outcome of disease-modifying therapies (DMTs), persistence could be used as a long-term clinical response indicator, integrating both effectiveness and safety. Our purpose is to examine persistence to DMTs of patients with Relapsing-Remitting Multiple Sclerosis (RRMS) at a large tertiary care academic medical center.
A retrospective, observational study was conducted in patients with RRMS who started DMTs with interferon-β (INF-β), glatiramer acetate (GA), teriflunomide, dimethyl fumarate (DF), fingolimod, natalizumab and alemtuzumab during 2016.
Persistence to DMTs was calculated until April 2019 and defined as the length of time on the drug. Variables analyzed were: demographics (sex, age), Expanded Disability Status Scale (EDSS) at baseline, number of previous DMTs, time to discontinuation, global persistence to therapy, persistence to each DMT and causes of discontinuation. Data were obtained from electronic health record.
131 subjects were followed for an average of 40 months. Median age was 42 years (21-68) and 62.6% were women. The median EDSS was 1(0-4.5) in naïve patients and 2(0-7) in pretreated patients. 71 patients were naïve (54.2%) and 60 pre-treated (45.8%). DMTs prescribed were: 38 IFN-β, 20 GA, 24 teriflunomide, 23 DF, 13 fingolimod, 8 natalizumab and 5 alemtuzumab. Median time to discontinuation (months (range)) of DMTs was 14(1-35), being longer in pretreated patients (15.5(1-31)) than in naïve patients (13(1-35)). Median time to discontinuation of each drug was: natalizumab 29(27-31), teriflunomide 18.5(2-35), fingolimod 16.5(3-29), GA 13.5(1-27), IFN-β 13(1-30) and DF 7.5(1-11). Global persistence was 67.2% and individual persistence by drug was: 100% alemtuzumab, 82.6% DF, 75% natalizumab, 70% GA, 69.2% fingolimod, 58.3% teriflunomide and 55.3% IFN-β.
Reasons for discontinuation were: intolerance/adverse effects (46.5%), lack of efficacy (32.6%), pregnancy/breastfeeding (9.3%), risk of progressive multifocal leukoencephalopathy (PML) (4.7%), fear of needles (4.7%) and patient decision (2.2%). The distribution of discontinuation due to adverse effect/intolerance was INF-β 58.8%, DF 50%, fingolimod 50%, teriflunomide 40% and GA 33.3%; and due to inefficacy: teriflunomide 60%, GA 33.3%, DF 25%, fingolimod 25% and INF-β 23.5%. Natalizumab only reason to discontinuation was high risk of PML.
Our cohort showed a high persistence rate (67.2%). Patients under treatment with INF and teriflunomide were most likely to discontinue (45% and 42%), being intolerance and inefficacy the main causes of discontinuation, respectively.
After those treated with alemtuzumab, patients on DF reported the fewest discontinuations (19%), mainly associated with intolerance.
DF presented the shortest time to discontinuation (7.5 months), whereas natalizumab (29 months) and teriflunomide (18.5 months) showed the longest.